Purchase the Archived Webinar Here (online)
Purchase
the Archived Webinar Here (offline)
If you missed the webinar on Key Messages from CDISC and FDA (CDER and CBER) on June 29, it’s not too late to hear our expert panel give the latest information about improving your clinical research processes and regulatory reviews through the use of standards.
What is covered in this 90 minute webinar:
- Learn how the full suite of CDISC standards (from protocol representation through analysis and reporting) will help you avoid costly legacy data conversions and save time and money on your next clinical research study.
- Learn the value of the new CDISC Protocol Representation Model in preparing for clinical trial registration, eSubmissions, clinical study reports and publications and using EHRs for research.
- Hear preliminary results from the most recent CDISC industry survey and a summary of key messages from CDISC.
- Listen as CDER and CBER representatives present and discuss their Standards Implementation Plans and provide up-to-date information for those planning eSubmissions to these FDA centers. From the presentations and Q&A session, learn more details on which FDA offices are accepting SDTM submissions, and what their expectations are.
Expert Panel:
Rebecca Kush, CDISC President and CEO
Amy Malla, MT(ASCP), PMP, CQA, CBER
Charles Cooper, MD, CDER
Frank Newby, CDISC COO